Comparison of Outcomes Between the Use of Silverlon® Dressing and AQUACEL® AG Dressing Post Cardiac Device Implant

The purpose of this study is to learn how effective each of the two dressings, Silverlon® and AQUACEL® AG, are in preventing post cardiac implantable electronic devices (CIED) procedure wound infections.

Study Overview

• Status: Completed
• Conditions: Wounds and Injuries; Infections
• Intervention / Treatment: Device: Silverlon®; Device: AQUACEL® AG

Detailed Description

This is a single center, prospective, 2-arm randomized, non-blinded study. A total of 100 participants will be assigned to the Silverlon arm and 100 to the AQUACEL AG arm.

The number of procedures to implant CIED has risen in recent years. With this rise has also brought a rise in post-procedure infections. Infections will happen and there is a continued need to improve all aspects of the surgery and post-operative care. Wound coverage with appropriate dressings is one aspect that needs to be studied in CIED implant patients. Silverlon and AQUACEL AG are two options of dressings available for these patients. This study will look to see if one of the two is a better option for post-operative CIED implant patients.

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who are scheduled for a CIED implant, generator change, or upgrade at the University of Kansas Hospital
• Able to give informed consent

Exclusion Criteria:

• Patients who are already on antibiotics for another reasons
• Immunocompromised patients such as those on immunosuppressant's and HIV positive patients
• Patients who are post device explant for lead infection
• Patients with an allergy to adhesive, silver or an allergy to the dressing(s) or their components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Silverlon®; Subjects randomized to this arm will receive Silverlon® dressing postoperative.	Device: Silverlon®; Silverlon wound dressings
Active Comparator: AQUACEL® AG; Subjects randomized to this arm will receive AQUACEL® AG dressing postoperative.	Device: AQUACEL® AG; AQUACEL® AG wound dressings

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pocket Hematoma, Moderate-Severe	A pocket hematoma is an accumulation of blood in or near the surgical incision which occurs because of a defect in hemostasis such as injury to blood vessels. Pocket hematoma is associated with local discomfort, an increased risk of infection, and may require surgical intervention or lead to lengthier hospital stays. Mild - Ecchymosis or mild effusion in the pocket, no swelling or pain to device-pocket (watchful waiting) Moderate - Large effusion in the pocket leading to swelling and causing functional impairment or pain to device-pocket Severe - Any pocket hematoma requiring: Reoperation and/or resulting in prolongation of hospitalization (defined as extended hospitalization or rehospitalization for >24 hours, postindex surgery, primarily due to hematoma) and/or requiring interruption of OAC (defined as reversal or intentional withholding, in response to pocket hematoma, resulting in subtherapeutic anticoagulation for >24 hours)	7-10 days post implant

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Drainage	Number of participants with wound drainage	At time of dressing removal, up to 10 days post operative
Pocket Dehiscence	Pocket (Wound) Dehiscence: Dehiscence is a partial or total separation of previously approximated wound edges, due to a failure of proper wound healing. It may be just the surface layer or the whole wound.This scenario typically occurs 5 to 8 days following surgery when healing is still in the early stages.	At time of dressing removal, up to 10 days post operative
Rash After Removal	Number of participants with rash after dressing removal	At time of dressing removal, up to 10 days post operative
Site Itching/Burning	Number of participants with Site itching/burning	At time of dressing removal, up to 10 days post operative
Skin Erythema	Number of participants with skin erythema	At time of dressing removal, up to 10 days post operative

Collaborators and Investigators

• Sponsor: Kansas City Heart Rhythm Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2017
• Study Completion (Actual): December 1, 2017

Study Registration Dates

• First Submitted: May 20, 2016
• First Submitted That Met QC Criteria: May 23, 2016
• First Posted (Estimate): May 24, 2016

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Cardiac Implantable Electronic Device; Implant
• Additional Relevant MeSH Terms: Wounds and Injuries; Gastrointestinal Agents; Laxatives; Carboxymethylcellulose Sodium
• Other Study ID Numbers: STUDY00003363

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No